MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-03-03 for X-STOP INTERSPINOUS SPACER SYSTEM UNK manufactured by Medtronic Sofamor Danek.
[101462007]
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[101462008]
It was reported that patient underwent an unknown surgery at l4-5. Post-op, patient reported hip and thigh pain. Pain started 5 months another surgery (hip replacement). Reportedly, patient underwent x-ray with imaging which showed that the device was fine and in good position, but may have bone growing around it. Surgeon has suggested removal and fusion, but has not decided to do that at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2018-00308 |
| MDR Report Key | 7312003 |
| Report Source | CONSUMER |
| Date Received | 2018-03-03 |
| Date of Report | 2018-03-03 |
| Date Mfgr Received | 2018-02-09 |
| Date Added to Maude | 2018-03-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STACIE ZIEMBA |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | MEDTRONIC SOFAMOR DANEK |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | X-STOP INTERSPINOUS SPACER SYSTEM |
| Generic Name | PROSTHESIS, SPINOUS PROCESS SPACER/PLATE |
| Product Code | NQO |
| Date Received | 2018-03-03 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SOFAMOR DANEK |
| Manufacturer Address | 1800 PYRAMID PLACE MEMPHIS TN 38132 US 38132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-03-03 |